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Набор по приглашению NCT07457333

Beta-sitosterol for Subarachnoid Hemorrhage: Mechanistic Analysis of Recovery and Therapy

Фаза I / Фаза II С лечением Subarachnoid Haemorrhagic Stroke

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Supplementation of β -sitosterol, Standard medical treatment.
Кому может быть актуально
Состояния в реестре: Subarachnoid Haemorrhagic Stroke. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Subarachnoid Hemorrhage (SAH), a devastating form of stroke, is associated with high mortality and disability rates due to complex secondary brain injuries-including neuroinflammation, oxidative stress, and blood-brain barrier disruption-for which effective neuroprotective treatments remain scarce. Inspired by the neuroprotective properties of the traditional Chinese herb Gastrodia elata, this study identifies a novel bioactive mechanism: its extracellular vesicles (G-EVs) are naturally enriched with β-Sitosterol, a plant sterol with proven anti-inflammatory, antioxidant, and endothelial-protective effects. This project represents the first clinical investigation into the therapeutic potential of β-Sitosterol for patients with aneurysmal SAH. Given the excellent safety profile of β-Sitosterol as a widely used dietary supplement, this study aims to evaluate its safety and tolerability in SAH patients while preliminarily exploring its efficacy in improving neurological outcomes. By analyzing key biomarkers of inflammation and oxidative stress, this research seeks to bridge the gap between traditional medicine and modern nanomedicine, offering a novel, safe, and accessible adjunct therapy for SAH and paving the way for plant-derived compounds in acute neurocritical care.

Вмешательства

  • Препарат Supplementation of β -sitosterol
    Participants in the experimental arm will receive Nutricost β-Sitosterol Softgels. The total daily dose is 500 mg of β-Sitosterol, administered orally in two divided doses (e.g., 250 mg twice daily). The treatment will continue for a duration of 6 months.
  • Другое Standard medical treatment
    Standard medical treatment

Первичные конечные точки

  • the modified Rankin Scale (mRS) score [Срок оценки: From baseline through the 6-month follow-up period (with intensive monitoring during the first 14 days).]
  • Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Срок оценки: At 90 days (±7 days) post-treatment initiation.]
Вторичные конечные точки (5)
  • Glasgow Outcome Scale Extended (GOS-E) score [Срок оценки: At 1 month, 3 months (±7 days), and 6 months (±14 days).]
  • Montreal Cognitive Assessment (MoCA) score [Срок оценки: At baseline (enrollment), 1 month, 3 months, and 6 months.]
  • Short Form Health Survey (SF-36) score [Срок оценки: At 90 days (±7 days) and 180 days (±14 days).]
  • Radiological Outcomes Assessed by MRI (Cerebral Infarction, Edema) [Срок оценки: At baseline, 1 month, 3 months, and 6 months.]
  • Serum Levels of Inflammatory Cytokines [Срок оценки: At baseline, 1 month, 3 months, and 6 months.]

Критерии участия

Критерии включения

  • Aged 18 to 75 years, regardless of gender.
  • Confirmed diagnosis of spontaneous aneurysmal subarachnoid hemorrhage (aSAH) by head CT or cerebral angiography (DSA/CTA).
  • Time from symptom onset to planned first dose administration within 48 hours.
  • Aneurysm successfully secured by surgical clipping or endovascular intervention.
  • World Federation of Neurosurgical Societies (WFNS) grade I-III.
  • Written informed consent signed by the patient or their legal representative.

Критерии исключения

  • Non-aneurysmal SAH (e.g., caused by trauma, arteriovenous malformation, etc.).
  • Secondary to other severe intracranial diseases (e.g., large intracerebral hematoma, severe brain herniation).
  • Complicated with severe cardiac, hepatic, renal, or hematopoietic system dysfunction (as defined by specific laboratory criteria).
  • Known allergy to Gastrodia elata or any of its components.
  • Pregnancy or breastfeeding.
  • Participation in another interventional clinical trial within 30 days prior to enrollment.
  • Any other condition that, in the judgment of the investigator, makes the patient unsuitable for participation in this study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • 2ndAffiliated Hospital, School of Medicine, Zhejiang Universit — Ханчжоу

Идентификаторы

NCT: NCT07457333 · 2026-0151

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗